RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.

PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in treating women who have stage I, stage II, or stage III breast cancer that has been surgically removed.

Condition	Treatment or Intervention	Phase
stage I breast cancer stage II breast cancer stage IIIA breast cancer	Procedure: adjuvant therapy  Procedure: low-LET electron therapy  Procedure: low-LET photon therapy  Procedure: radiation therapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare the effect of irradiation of the homolateral internal mammary and medial supraclavicular lymph node chains vs no further therapy on survival, disease-free survival, metastasis-free survival, and cause of death in women with resected stage I/II/III breast cancer.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution, tumor location, type of prior breast surgery, pathologic T and N stage, menopausal status, and time sequence of radiotherapy and adjuvant chemotherapy. Patients are randomized to 1 of 2 arms.

• Arm I: Patients receive no nodal irradiation.
• Arm II: Patients receive irradiation of the internal mammary and medial supraclavicular lymph node chains delivered at 1 fraction per day, 5 sessions per week, for a total of 25 fractions over 5 weeks. Radiotherapy must begin no later than 8 weeks after surgery. If adjuvant chemotherapy is given, radiotherapy begins within 6 weeks after the last course of chemotherapy and within 8 months after surgery. Patients are followed at least yearly after randomization for up to 20 years.

PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years.

Ages Eligible for Study:  up to  75 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed unilateral adenocarcinoma of the breast
• Stage I/II/III (Tx, T0-3, N0-2) disease in one of the following categories or multifocal tumors if one of the foci is in agreement with the following:
• Centrally or medially located with any lymph node status
• Central location defined as underlying the areola
• Medial location defined as at least partial involvement of upper or lower medial quadrant of breast
• Externally located with axillary node involvement
• Prior mastectomy or breast-conserving surgery and axillary dissection required
• Sentinel node procedure as axillary intervention without further axillary surgery is allowed
• No prior internal mammary chain dissection
• No upper inner lesion treated with breast-conserving surgery that precludes sparing of internal mammary lymph node chain from radiotherapy volume
• Decision at radiation oncologist's discretion
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age:

• 75 and under

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No prior cardiac disease

Other:

• No prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

Other:

• Concurrent enrollment in other randomized trials allowed

Belgium
      Algemeen Ziekenhuis Sint-Augustinus, Wilrijk,  2610,  Belgium
      Cazk Groeninghe - Campus Maria's Voorzienigheid, Kortrijk,  B-8500,  Belgium
      Cliniques Universitaires Saint-Luc, Brussels,  1200,  Belgium
      Hopital de Jolimont, Haine-Saint-Paul,  7100,  Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
      Ziekenhuis Network Antwerpen Middelheim, Antwerp,  2020,  Belgium
Bosnia and Herzegovina
      Institute of Oncology - Clinical Center University of Sarajevo, Sarajevo,  71000,  Bosnia and Herzegovina
Chile
      Clinica Alemana, Santiago,  5951,  Chile
      Instituto de Radiomedicina, Santiago,  10,  Chile
France
      Centre Antoine Lacassagne, Nice,  06189,  France
      Centre de Lutte Contre le Cancer Georges-Francois Leclerc, Dijon,  21079,  France
      Centre Eugene Marquis, Rennes,  35042,  France
      Centre Hospitalier Universitaire Henri Mondor, Strasbourg,  67085,  France
      Centre Leon Berard, Strasbourg,  67085,  France
      Centre Paul Strauss, Strasbourg,  67085,  France
      CHR de Besancon - Hopital Jean Minjoz, Besancon,  25030,  France
      CHU de Grenoble - Hopital de la Tronche, Grenoble,  38043,  France
      Institut Bergonie, Bordeaux,  33076,  France
      Institut Gustave Roussy, Strasbourg,  67085,  France
      Service Cancerologie Polyclinique Clairval, Marseille,  13009,  France
Germany
      Charite - Campus Charite Mitte, Berlin,  D-10117,  Germany
      Klinik I fuer Innere Medizin, Cologne,  D-50924,  Germany
      Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch, Berlin,  D-13122,  Germany
      Universitaetsklinikum Essen, ESSEN,  D-45122,  Germany
      Universitaetsklinikum Goettingen, GOETTINGEN,  D-37075,  Germany
      Universitaetsklinikum Tuebingen, Tuebingen,  D-72076,  Germany
      University of Erlangen-Nuremberg, Erlangen,  DOH-91054,  Germany
Israel
      Chaim Sheba Medical Center, RAMAT-GAN,  52621,  Israel
      Rambam Medical Center, Haifa,  31096,  Israel
Italy
      Istituto Nazionale per la Ricerca sul Cancro, Genoa (Genova),  16132,  Italy
      Ospedale Sant Anna, Como,  22100,  Italy
Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands
      Academisch Ziekenhuis Groningen, Groningen,  9713 GZ,  Netherlands
      Academisch Ziekenhuis Utrecht, Utrecht,  3584 CX,  Netherlands
      Dr. Bernard Verbeeten Instituut, Tilburg,  5042 SB,  Netherlands
      Medisch Centrum Haaglanden, 's-Gravenhage (Den Haag, The Hague),  2501 CK,  Netherlands
      Medisch Spectrum Twente, ENSCHEDE,  7500 KA,  Netherlands
      Radiotherapeutisch Instituut Limburg-Maastricht, Maastricht,  NL-6229 ET,  Netherlands
      Radiotherapeutisch Instituut-(Riso), Deventer,  7400 AC,  Netherlands
      Streekziekenhuis Gooi-Noord, Blaricum,  1261 AN,  Netherlands
Poland
      Medical University of Gdansk, Gdansk,  80-211,  Poland
Portugal
      Instituto Portugues de Oncologia Centro do Porto, SA, Porto,  4200-072,  Portugal
Spain
      Institut Catala D'Oncologia, Barcelona,  08907,  Spain
Switzerland
      Centre Hospitalier Universitaire Vaudois, Lausanne,  CH-1011,  Switzerland
      Hopital Cantonal Universitaire de Geneve, Geneva,  CH-1211,  Switzerland
      UniversitaetsSpital, Zurich,  CH-8091,  Switzerland
Turkey
      Istanbul University-Institute of Oncology, Istanbul,  34390,  Turkey
United Kingdom, England
      Nottingham City Hospital NHS Trust, Nottingham,  England,  NG5 1PB,  United Kingdom

Study chairs or principal investigators

Walter F. Van den Bogaert, MD, PhD,  U.Z. Gasthuisberg   
H. Struikmans, MD, PhD,  Medisch Centrum Haaglanden   
Alain Fourquet, MD,  Institut Curie - Section Medicale   
Harry Bartelink, MD, PhD,  Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital   

Study ID Numbers:  CDR0000065094; EORTC-10925; EORTC-22922; NCT00002851
Record last reviewed:  February 2005
Last Updated:  February 8, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002851
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08